The Friday Five – Five of the past week's stories you can't afford to ignore...

Landmark biosimilar approval

History was made on Tuesday when the European Commission approved Europe's first biosimilar monoclonal antibody (MAb) product – a biosimilar version of Remicade that will be marketed by Hospira under a license from Celltrion and sold as Inflectra.

For a more in-depth analysis of Inflectra and the implications of EU approval, FirstWord Pharma PLUS clients can click here.

US diabetes marketing battle to remain a key industry trend

Sanofi may have confirmed on Thursday that it will delay filing its GLP-1 agonist lixisenatide in the US for a number of years (see ViewPoints: Sanofi's lixisenatide gamble?), but the entry of new products into the diabetes space may provide pharmacy benefit managers (PBMs) the opportunity to extract additional discounts, Sanford C. Bernstein analyst Ronny Gal told FirstWord this week.

With efficacy and safety differentiation within the various drug classes limited, the diabetes marketing battle is set to intensify, and PBMs will be looking to push down prices given that diabetes accounts for a large proportion of expenditure, added Gal.

While the setback to lixisenatide means that Sanofi's position in the US diabetes market will be focused on the continued success of Lantus over the next few years, competitor Eli Lilly is hoping to launch a biosimilar version of that drug in 2014.

It remains to be seen whether biosimilar insulins marketed by leading players, such as El Lilly, have a profound effect on the pricing of branded competitors, adds Gal, given that they will– at least initially – be positioned as 'near-branded' offerings. However, crucial to Eli Lilly – a company spokesperson told FirstWord – is the ability to provide the broadest portfolio of diabetes products in the industry, an approach that could both differentiate the company and increase its competitiveness if BPMs continue to exert increased discounting pressure.

For further analysis see ViewPoints: Express Scripts and other PBMs eyeing up pricing battle in US diabetes market?

Ups and downs at GlaxoSmithKline

A busy week for GlaxoSmithKline saw a positive outcome from its AdCom panel for Anoro Ellipta – a potential first-in-class LAMA/LABA combination for the treatment of COPD – at least partially offset by guidance from the FDA that appears to have lowered the regulatory bar for the approval of generic respiratory products.

The FDA guidance document effectively increases the risk of generic competition to GlaxoSmithKline's $8-billion Seretide/Advair franchise; a brand that the company is looking to reduce its dependency on via the launches of Anoro and Breo Ellipta – a once-daily follow-up to Seretide/Advair – which was approved in May.

See also Spotlight On: FDA shifts landscape for generic respiratory products – is GlaxoSmithKline's $8 billion Seretide/Advair franchise in the firing line?

Divergent R&D trends at AstraZeneca, Merck & Co. ...

Licensing deals signed between two of the industry's biggest players are always interesting developments and an example this week – AstraZeneca's move to in-license the WEE1 kinase inhibitor MK-1775 from Merck & Co. – is a case in point. With R&D among Big Pharma companies under almost constant scrutiny, it is difficult to see such a deal producing a scenario whereby both players ultimately look like they have won.

That aside, the deal does appear to encapsulate the opposing strategies taking place at the two companies – a more focused approach at Merck – where cancer immunotherapies are now positioned front and centre – and efforts at AstraZeneca to revitalise the pipeline via various in-licensing and acquisitions - see ViewPoints: Bold move or misjudged enthusiasm? – AstraZeneca looks to get ahead in the PARP inhibitor race.

Roger Perlmutter – the relatively new head of R&D at Merck – gave further insight into his vision for the company's drug discovery and development efforts at a meeting with sell-side analysts at the beginning of the week. Expect further structural changes to Merck's R&D organisation and investment in biologics based on Perlmutter's comments. The all important question as to whether the company will cut its R&D expenditure significantly remains unanswered - see ViewPoints: R&D chief Roger Perlmutter prescribes an increased dose of biologics for Merck & Co.'s R&D pipeline.

...but both companies looking to expand immunotherapy portfolios

One key similarity at AstraZeneca and Merck is set to be the importance that cancer immunotherapies play in the pipelines at both companies in the coming years. Comments from management at both drugmakers indicate that licensing and acquisitive behaviour may continue as a means to bolster opportunities and develop the best available combinations if success is to be secured in a market that some analysts are already predicting could be worth $35 billion - see ViewPoints: Will cancer immunotherapies drive the next wave of Big Pharma M&A?

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